NCT00275418

Brief Summary

Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants that are present in many natural food sources may provide protection from such damage. Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene. In this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
Last Updated

January 12, 2006

Status Verified

January 1, 2006

First QC Date

January 10, 2006

Last Update Submit

January 10, 2006

Conditions

Crohn's Disease

Keywords

Crohn's diseaseremissionbeta carotene

Outcome Measures

Primary Outcomes (1)

  • CDAI score measured 3-monthly during treatment

Interventions

beta carotene from Dunaliella algaeDRUG

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with documented Crohn's disease in remission (CDAI\<150) for at least two months, age 17-75 years

You may not qualify if:

  • active Crohn's disease (CDAI\>150), partial bowel obstruction, impending surgery, pregnancy, serious other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Alexandra Lavy, MD

    Technion, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Carlebach, MD

CONTACT

+ 972-4-8359426matthias.carlebach@b-zion.org.il

Alexandra Lavy, MD

CONTACT

+ 972-4-8359736lavya@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

July 1, 2002

Last Updated

January 12, 2006

Record last verified: 2006-01

Locations

IL(1)